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The Nutrition and Health Claims Regulation Applies to Commercial Communications Addressed to Health Professionals

Published online by Cambridge University Press:  20 January 2017

Marco de Morpurgo  and
Patricia Carmona Botana
Marco de Morpurgo
Affiliation:
Allen & Overy LLP; University of Trieste; marco.demorpurgo@allenovery.com
Patricia Carmona Botana
Affiliation:
Allen & Overy LLP; patricia.carmonabotana@allenovery.com
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Abstract

Case C-19/15 Verband Sozialer Wettbewerb eV v Innova Vital GmbH (ECJ, 14 July 2016)

On 14 July 2016, the Court of Justice delivered its judgment on a request for a preliminary ruling concerning the interpretation of Article 1(2) of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. The Court ruled for the first time that the Regulation applies to nutrition and health claims made in commercial communications exclusively addressed to health professionals. This represents a major breakthrough as – in a climate of uncertainty – the established industry practice was to interpret Article 1(2) in the sense that the Regulation only applied to commercial communications addressed to final consumers. From now on, food business operators will need to take further precautionary steps to ensure that any information they communicate to health professionals either qualifies as non-commercial or complies with the Regulation. The following case note analyses the content of the judgment and its main implications (authors' summary).

Type
Case Notes
Information
European Journal of Risk Regulation , Volume 7 , Issue 3 , September 2016 , pp. 634 - 641
Copyright
Copyright © Cambridge University Press 2016

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References

*** Article 1(2) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods (OJ L 404, 30.12.2006, p. 9-25, and corrigendum OJ L 12, 18.1.2007, p. 3-18), last amended by Commission Regulation (EU) No 1047/2012 of 8 November 2012 (OJ L 310, 9.11.2012, p. 36-37).

1 Supra note ***.

2 Case C-19/15 Verband Sozialer Wettbewerb eV v Innova Vital GmbH (14 July 2016), para. 14.

3 Art. 2(1)(a) NHCR refers to the definition of ‘final consumer’ set out in Regulation (EC) No 178/2002 on food law. Art. 3(18) of Regulation 178/2002, as amended, defines ‘final consumer’ as “the ultimate consumer of a foodstuff who will not use the food as part of any food business operation or activity.”

4 Case C-19/15 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, Opinion of AG Saugmandsgaard Øe (18 February 2016), para. 32.

5 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, supra note 2, para. 22.

6 Opinion of AG Saugmandsgaard íe, supra note 4.

7 Directive 2000/31/EC on information society services and electronic commerce (OJ L 178, 17.07.2000, p. 1-16).

8 Directive 2006/123/EC on services in the internal market (OJ L 376, 27.12.2006, p. 36-68).

9 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, supra note 2, para. 29.

10 Ibid., para. 30. The CJ focused on the scenario where health professionals receive the commercial communication in their professional capacity and not as final consumers. The AG noted that there can indeed be little doubt as to the applicability of the NHCR in the latter case – where the professional is the final consumer of the product –, as in such case the communication is directly received by the final consumer (Opinion of AG Saugmandsgaard íe, supra note 4, footnote 31).

11 Opinion of AG Saugmandsgaard Øe, supra note 4, para. 41.

12 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, supra note 2, para. 31.

13 Opinion of AG Saugmandsgaard Øe, supra note 4, para. 42.

14 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, supra note 2, para. 32.

15 Ibid., para. 35.

16 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, supra note 2, paras. 43-45.

17 Ibid., para. 46. For the AG, this would result in depriving the NHCR of part of its practical effect “particularly in so far as the absence of a prior assessment by the EFSA would enable the use of health claims which are not based on scientific evidence” (Opinion of AG Saugmandsgaard Øe, supra note 4, para. 51).

18 Opinion of AG Saugmandsgaard Øe, supra note 4, para. 50.

19 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, supra note 2, para. 51.

20 Opinion of AG Saugmandsgaard Øe, supra note 4, para. 54.

21 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, supra note 2, paras. 52-53.

22 Ibid., para. 54.

23 Opinion of AG Saugmandsgaard Øe, supra note 4, para. 58.

24 As the AG reminded in his Opinion, it is for the national court alone to assess and characterise the facts giving rise to the dispute in the main proceedings and to apply the relevant provisions of EU law as interpreted by the CJ to national situations (e.g. Case C-81/12 Asociaţia ACCEPT v Consiliul Naţional pentru Combaterea Discriminării (25 April 2013), paras. 41-43; and Case C-609/12 Ehrmann AG v Zentrale zur Bekampfung unlauteren Wettbewerbs eV (10 April 2014), para. 36) (Opinion of AG Saugmandsgaard Oe, supra note 4, para. 27).

25 Regulation (EU) No 1169/2011 on the provision of food information to consumers (OJ L 304, 22.11.2011, p. 18-63, and corrigendum OJ L 247, 13.9.2012, p. 17), as amended.

26 Subject to derogations provided within the EU framework applicable to natural mineral waters and foods for particular nutritional uses (currently known as foods for specific groups). See Article 7(3) Regulation (EU) No 1169/2011, supra note 25.

27 Directive 2000/13/EC on the labelling, presentation and advertising of foodstuffs (OJ L 109, 6.5.2000, p. 29–42, and corrigendum OJ L 124, 25.5.2000, p. 66), as amended. See in particular Art. 2(1)(b).

28 Opinion of AG Saugmandsgaard Øe, supra note 4, in particular paras. 30-31.

29 For example, the Department of Health of the United Kingdom considered that “[w]hile the Regulation applies to claims made in commercial communications about foods it is our opinion that it will not control claims made in communications within trade (business to business), to doctors or other health professionals, or to their organisations, whether the claim is in the labelling, advertising or other presentation of the food. This is provided that the recipients are acting within the scope of their professional activities and that they are not being addressed as final consumers of the foods. It therefore follows that if the information were, at any time, conveyed to final consumers within a commercial context, any claims made would need to comply with the requirements of the Regulation” (Guidance to compliance with Regulation (EC) 1924/2006 on nutrition and health claims made on foods, November 2011 version, para. 35). The Belgian healthcare authorities published a letter acknowledging that, while the article did not state it explicitly – thereby, acknowledging the ambiguity in its wording – the national position was such that the NHCR did not apply to communications either addressed to health professionals or between businesses so long as such communications are not transferred to the final consumer within a commercial context, or are easily accessible to him (e.g. via a website with free access) (Federal Public Service, Health, Food Chain Safety and Environment, letter from Director General Dr. P. Mortier, ‘Reglement 1924/2006 – Clarification du champ d’application’, September 2013).

30 Department of Health of the United Kingdom, Nutrition and Health Claims Interested Parties Letter of 27 January 2012, Update from the European Commission's Working Group meeting on nutrition and health claims, 23 January 2012. See in particular answer to question 2.

31 Ibid., see answer to question 2, first para.

32 Ibid., see answer to question 2, second para. We note in particular the Dutch, French and Hungarian versions of the NHCR.

33 We identified at least the Danish version of the NHCR supporting this interpretation. The German wording is also open to such interpretation, while the Belgian authorities have also acknowledged the absence of a clear wording within Art. 1(2) (supra note 29). In this respect, according to settled case-law “[…] interpreting a provision of Union law involves a comparison of the language versions […]. Where there is divergence between the various language versions, the provision in question must be interpreted by reference to the purpose and general scheme of the rules of which it forms part […]”. See Case C-207/14 Hotel Sava Rogaška, Gostinstvo, turizem in storitve, d.o.o. v Republika Slovenija (24 June 2015), paras. 26-28. The CJ followed this approach in this case (see Section III.2.a).

34 We note that the AG, in his Opinion, referred to the existence of a German stream of scholarship precisely addressing alternative interpretations of Article 1(2) NHCR. However, the AG did not explicitly address this literature. Opinion of AG Saugmandsgaard Oe, supra note 4, para. 33.

35 See Section III.2.b.

36 The average consumer benchmark has been applied within the context of NHCR proceedings. See e.g. case T-100/15, Dextro Energy GmbH & Co. KG v European Commission (16 March 2016), where the General Court recalled that “[a]s is apparent from recital 16 of Regulation No 1924/2006, in order to resolve the question whether a claim is misleading or not, it is necessary to refer to the presumed expectations in relation to that claim which an average consumer who is reasonably well informed, and reasonably observant and circumspect, would have […]” (para. 66). See also Case C-609/12 Ehrmann AG v Zentrale zur Bekampfung unlauteren Wettbewerbs eV. (10 April 2014), para. 40 (“[…] as Article 1 of Regulation No 1924/2006 states, the regulation aims to ensure the effective functioning of the internal market whilst providing a high level of consumer protection. In that regard, recitals 1 and 9 in the preamble to that regulation explain that it is necessary in particular to give the consumer the necessary information to make choices in full knowledge of the facts”); case T-100/15, Dextro Energy GmbH & Co. KG v European Commission (16 March 2016), paras. 66 and 85; case C-157/14 Société Neptune Distribution v Ministre de l'Économie et des Finances (17 December 2015), para. 49; and case T-17/12, Moritz Hagenmeyer and Andreas Hahn v European Commission (30 April 2014), para. 105.

37 Opinion of AG Saugmandsgaard Oe, supra note 4, para. 54.

38 In this respect, as the AG stated, “it is irrelevant whether professionals pass on the document they have received onto consumers as it is or they pass on only the substance of that document, the main point being, in my view, that the nutrition and health claims made in that document, which fall within the scope of that regulation, may be communicated to the final consumers, even indirectly, as in the present case.” Ibid., para. 44.

39 The CJ recalled this dual objective sought by the NHCR, stating that health protection is among the principal aims of the NHCR, in many instances. See e.g. case T-17/12, Moritz Hagenmeyer and Andreas Hahn v European Commission (30 April 2014), para. 105; and case T-100/15, Dextro Energy GmbH & Co. KG v European Commission (16 March 2016), paras. 33 and 85.

40 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, supra note 2, paras. 52-53. See also supra Section III.2.c.

41 Opinion of AG Saugmandsgaard Øe, supra note 4, para. 32.

42 While this judgment relates to communications to health professionals, food business operators should take it into account when communicating with other professionals ('business-to-business’) as well to minimise risks.

43 Sections III.2.b and IV.2.

44 Verband Sozialer Wettbewerb eV v Innova Vital GmbH, supra note 2, para. 14.

45 Ibid., para.15. See also Opinion of AG Saugmandsgaard Øe, supra note 4, para. 17.